Has novel food been authorised in the EU?
Up until the beginning of 2015, there have been around 180 applications (7-10 applications/year). So far around 80 novel foods have been authorised for use in the EU. Authorised novel food include products traditionally eaten in non-EU countries such as "noni juice" (made from a Tahitian plant), and food produced using the latest technological innovations such as oils and dairy products enriched with phytosterols/phytostanols to reduce cholesterol. Other examples include "salatrim" a reduced-energy fat, DHA-rich oil and a high-pressure fruit juice (which is an example of a food derived from new production processes).
What are the requirements for a novel food to be authorised for use in the EU?
Novel food will only be approved for use in the EU if they do not present a risk to public health, are not nutritionally disadvantageous when replacing a similar food and are not misleading to the consumer. They must undergo a scientific assessment prior to authorisation to ensure their safety. The authorisation sets out, as appropriate, the conditions for their use, their designation as a food/food ingredient and labelling requirements.
Novel Food Regulation does not apply in the following cases:
Food additives within Regulation EC 1333/2008
Flavourings for use in foods within Regulation EC 1334/2008
Extraction solvents used in the production of foods within Directive 2009/32/EC approximating EU countries' laws
If foods and/or food ingredients were used exclusively in food supplements, new uses in other foods require an authorisation under the Novel Food Regulation e.g. food fortification requires an authorisation.
Request for an authorisation and risk assessment
To market a novel food or ingredient, companies must apply to a Member State competent authority for authorisation , presenting the scientific information and safety assessment report
The competent authority decides if an additional assessment by the European Food Safety Authority is necessary
The competent authority allows the marketing of the product if no additional assessment is necessary, and if the Commission and other EU countries do not object
If a Commission decision is needed, the Commission asks the Standing Committee on Plants, Animals, Food and Feed for an opinion
The notification procedure
A novel food or ingredient may be marketed through a simplified procedure called "notification" (Article 5 of Regulation (EC) No 258/97). The company notifies the Commission about their intention to place on the market a novel food or ingredient based on the opinion of a Member State food assessment body that has established "substantial equivalence" to an already authorised novel food.
The Authorisation covers:
- Conditions of use
- Designation of novel food or novel food ingredient
- Specification and labelling requirements
Novel food is subject to the general labelling requirements (Regulation 1169/2011). Specific additional requirements for the labelling of novel food may also apply, if necessary to properly inform the consumer. The label must mention the name of the food, and, where appropriate, specify the conditions of use. Any nutrition and health claim should only be made in accordance with the Health and Nutrition Claims Regulation 1924/2006.